FDA advisory committee member reportedly resigns over Alzheimer’s therapy approval

A member of the FDA’s expert panel for nervous system therapies reportedly resigned over the decision to authorize an Alzheimer’s therapy.

The FDA controversially authorized Aduhelm (aducanumab) from Biogen on Monday, making it the first novel Alzheimer’s drug treatment in 18 years despite drug companies pumping billions of dollars into more than 400 clinical trials.

STAT News reported yesterday that Joel Perlmutter, a neurologist at Washington University (St. Louis) and a member of the FDA’s expert panel for nervous system therapies, told the outlet that he quit the committee on Monday “due to this ruling by the FDA without further discussion with our advisory committee.”

In March, three FDA advisory committee members — none of them Perlmutter — published an editorial in JAMA expressing reservations about aducanumab’s clinical trial data. The FDA’s approval of the drug is conditional, with Biogen required to run a confirmatory clinical…

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Biogen’s stock pops nearly 40% after FDA’s Alzheimer drug approval, but questions remain

FDA has approved the Aduhelm (aducanumab) from Biogen, the first novel Alzheimer’s drug treatment, in 18 years despite drug companies pumping billions of dollars into more than 400 clinical trials.

The news caused Biogen’s share price to jump from $286.14 to $395.85 — a 38.34% increase.

It remains to be seen, however, just how big of a blockbuster Aduhelm will be. Some Alzheimer’s experts have stressed that they won’t prescribe aducanumab, citing a lack of convincing evidence that it is effective. Last November, an FDA advisory committee also expressed reservations about aducanumab’s clinical trial data. Three of those members explained their reasoning in a March editorial in JAMA.

But optimists stress that Aduhelm’s approval could also mark a turning point in treating Alzheimer’s disease (AD). “Aduhelm is the first therapy to target and affect the underlying disease process of AD,” said Alessio Brune…

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Scientists create first human-monkey embryo

In this monkey-human embryo, human cells glow in red. [Image courtesy of Weizhi Ji / Kunming University of Science and Technology]

A group of scientists from the U.S. and China injected human stem cells into 132 macaque embryos, which then developed for up to 20 days.

While the research holds promise for organ transplants, studying disease and testing new drugs, it also prompts controversy.

The research was published this month in Cell.

The scientists began with blastocysts from macaques. They injected 25 human extended pluripotent stem cells into each of those cells, which replicate in the embryos’ tissue.

Researchers have previously injected human stem cells into organisms ranging from rodents to cattle to nonhuman primates to create chimeras. Previous research includes mice with human immune systems for AIDS research and rats with human tumors.

But the growth of human stem cell…

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Biogen moves forward with aducanumab launch plans 

Biogen’s (NSDQ:BIIB) Alzheimer’s drug aducanumab seemed to be a potential blockbuster until an FDA advisory committee voiced skepticism in November about the drug.

FDA reviewers had previously assessed the drug’s prospects more positively.

The company is preparing for the event of an FDA approval of the drug in June.

Biogen’s CEO Michel Vounatsos said in an analyst call today that he expects the antibody drug to sell well given the surging numbers of Alzheimer’s patients in the U.S. and elsewhere. “We anticipate if approved, there will be a large influx of patients,” Vounatsos concluded.

The company has argued that aducanumab slows disease progression in Alzheimer’s patients, which is a feat that no other FDA-approved drug can manage. But critics have argued that the company has failed to demonstrate that the drug is effective and have expressed concern over the drug’s potential to cause amyloi…

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What is needed to develop disease-modifying therapies for Parkinson’s and Alzheimer’s 

Photo by Edward Jenner from Pexels

Developing disease-modifying therapies for neurodegenerative diseases remains a pressing need.

The incidence of neurodegenerative disease is ramping up in the U.S. and elsewhere as much of the global population ages. One out of three seniors dies with Alzheimer’s disease or another form of dementia, according to the Alzheimer’s Association.

Parkinson’s disease is also becoming more widespread. Between 2015 and 2040, the number of people with Parkinson’s could nearly triple, rising from 6.3 to 17.5 million.

But developing drugs that can slow or stop the progression of such diseases poses a significant challenge for drug developers. Eli Lilly’s donanemab, for instance, showed promise earlier this year in treating Alzheimer’s in a Phase 2 study summarized in NEJM.

Another Alheimer’s candidate, aducanumab from Biogen, has also shown promise, although late l…

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How to build a foundation for the next phase of Alzheimer’s disease research

[Photo by Tim Doerfler on Unsplash]

Alzheimer’s disease has one of the highest financial burdens. The Alzheimer’s Association estimates that the cost of the disease in the U.S. will hit $355 billion in 2021. 

“Not only is Alzheimer’s one of the most expensive, it’s probably one of the most devastating diseases of humans,” said Dr. Allan Levey, professor and chairman of the department of neurology at Emory University. 

However, only symptomatic treatments are available, doing nothing to slow or stop disease progression. “There’s not a single disease-modifying agent, and Alzheimer’s is now the sixth most common cause of death,” Levey said. 

[Related: Why Genuity and Emory are partnering on neurodegenerative disease research] 

The last FDA-approved drug for Alzheimer’s was approved in 2003. 

But there’s reason for…

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